Biosimilars
EMA receives second application for biosimilar infliximab
According to EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use released in September 2012, the agency will be reviewing a second application for a biosimilar version of infliximab.
Bioton and Medipolis sign insulin analogue technology licensing agreement
Polish biotechnology company Bioton and Finnish-based contract research organisation (CRO) Medipolis GMP (Medipolis) have signed a licensing agreement on the manufacturing technology of an insulin analogue.
Naming and interchangeability of biosimilars raised in new survey
The contentious issues of naming and interchangeability of biosimilars in the US have been raised once again, as a result of a survey carried out by the Alliance for Safe Biologic Medicines (ASBM). The survey, released on 13 September 2012, examined physician practices and perspectives with regard to identification and substitution of biosimilars. These remain issues that are as yet unresolved by FDA.
Roche does not see a threat from biosimilars until 2015
Switzerland-based drugmaker F. Hoffmann-La Roche (Roche) expects results from 19 late-stage clinical trials over the next 18 months to provide a stream of products to offset potential near-term threats to its cancer drugs Herceptin (trastuzumab) and Rituxan (rituximab).
Boehringer Ingelheim starts biosimilar rituximab trial
Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) is starting a Phase III trial for a biosimilar version of rituximab.
Sun recalls biosimilar brain treatment
India-based Sun Pharmaceutical Industries (Sun Pharma) is once again in the news, but for the wrong reasons.
Biosimilar comparability debate continues
Authors Schellekens and Moors comment on the response from EMA’s Biosimilar Medicinal Products Working Party to questions that they raised regarding EMA’s comprehensive biosimilar regulatory pathway [1]. While the authors express their appreciation of the openness of EMA in the way it has pioneered the biosimilars pathway in Europe, they still argue that EMA has failed to show the scientific need for biosimilar comparability [2].
Teva receives FDA approval for filgrastim in the US
Teva Pharmaceutical Industries (Teva) announced on 30 August 2012 that FDA had granted approval for tbo-filgrastim (XM02 filgrastim), the first new granulocyte colony-stimulating factor (G-CSF) to be approved in the US in more than 10 years.
Dr Reddy’s plans EU launch for biosimilar rituximab
India-based generics drugmaker Dr Reddy’s Laboratories (Dr Reddy’s) is planning to launch its biosimilar monoclonal antibody Reditux (rituximab) in Europe.
EMA responds to questions over biosimilar comparability
EMA has responded to questions regarding its comprehensive biosimilar regulatory pathway. The pathway, which includes the need for new clinical trials and comparability studies that demonstrate quality, efficacy, and safety, has been accused of proving to be a barrier for the development of clinically superior compounds [1].
